October 18, 2007

Scott's Web Log just published the news that in an amazing triumph of common sense over marketing dollars, Pfizer is pulling Exubera off the market.

When Exubera launched, I was quoted in Business Week (complete with horrible photo) as a "typical patient." I said I would not use Exubera because it had some serious problems.

The journalist did not go into what those problems were, though I had spelled them out in some detail, but the main one was that Exubera was a bolus (mealtime) insulin that was supposed to be dosed by the patient's body weight, not by the carbohydrate content of the meal.

That's just plain nuts.

I'm extremely insulin sensitive and dosing Exubera by my body weight would have been likely to send me to the hospital with a severe hypo, as it would have resulted in my taking a dose several times higher than what I actually use. In addition, Exubera was supplied in packs, but a one pack dose was not 1/2 of a 2 pack dose. Titrate that!

Investors did not respond well to my words in Business Week and in the comments section of the Business Week articles I was labeled "an idiot with a computer." I've taken pride in that ever since, and I'm thrilled that the judgment of this idiot with a computer has been vindicated by the medical community who refused to prescribe Exubera despite billions of dollars of money spent on marketing it.

Now if only my warnings on Januvia could get a bit of attention in the media . . . As proud as I am of calling Exubera correctly, this idiot with a computer really doesn't want to be proven right on Januvia by the discovery years from now that it caused hundreds or thousands of unnecessary patient deaths.

BTW, I owe Pfizer this much, that had it not been for the Exubera flap I wouldn't have started this blog. The journalist who interviewed me found me on the diabetes newsgroup, alt.support.diabetes, but described me in print as "a blogger." I figured if I was going to be called a blogger, I better blog, so I did, which has turned out to be a very good decision.

4
comments:

Whilst I do understand your issues with the Exubera productI do think you are missing the bigger picture. The product was not right for you, ok, but it is right for people who are unable or unwilling to inject themselves. I am sure there are many people who, whilst you are rejoicing in your accomplishment are now wondering what is going to happen to them without being able to take their insulin. I think you also need to think about the impact that this decision is going to have on new drugs for our condition, and for other diseases in general.

That there are many people who won't use insulin at all because Exubera is off the market is belied by the fact that the same people who supposedly wouldn't take insulin due to injection fears have made Byetta a huge bestseller.

Byetta not only requires injection, it can cause severe nausea and projectile vomiting. People love it because it offers the hope (not always fulfilled) of weight loss.

Exubera didn't work very well and the predatory pricing, 3 times as high as the already overpriced analog insulins in combination with the fact it gave much poorer control than analogs made it a very poor drug.

Drugs that work continue to earn huge market share. Sometimes too huge. But Exubera was poorly thought out and the company tried to substitute advertising muscle for good product.

I think we should all be glad that approach failed, and we should also applaud leaders in the endocrinology community who stood up publicly and labeled Exubera "A very bad idea" which is what it was.

I think this is a vindication of sorts for many of us, whose input should have been considered when they were developing marketing for this product. However, its worth noting that just last month, on September 25 at the UBS 2007 Global Life Sciences Conference, Eli Lilly was noting that its "AIR® Inhaled Insulin" product is now in Phase III clinical trials, and the company expects to submit it for approval in the U.S. and Europe in 2009. Perhaps Wall Street will see this product for what it is, and give the stock for the company a proper evaluation?

Also worth noting: in Lilly's Q3 earnings release, Humalog sales may have increased by 12% during the quarter to $363 million, but thats largely due to price increases. Sales trends for Humalog are down, but in a big surprise, Humulin (largely consisting of Regular and NPH) sales, the products that were supposed to be dead, increased 6% to $243 million.

Perhaps some sense is returning to the Rx market? We can only hope, but I do think this is a good sign that these products are unlikely to be taken off the market anytime soon. Novo has every intention to eliminate "human" insulin from the market, but Lilly may think differently given the surprising strength of these old standbys (especially since they do not have a long-acting analog to replace them with).

As a devoted Humulin buyer, I sure hope they keep both R and NPH on the market.

After years of hearing terrible things about NPH I started using it last month, and much to my surprise, it works VERY well for me--perhaps because I'm using such a small dose.

I had significant problems with both Lantus and Levemir and cannot use either, so NPH is my only basal choice right now.

I read the report you published about one of the inhalable insulins that was supposed to be more physiological in its response curve, though I got the impression it was Type 2 only which suggests dosing issues there, too, since people seem to think giving Type 2 random doses that aren't titrated to food is somehow a great idea.

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